NCT01873716

Brief Summary

This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated carotid endarterectomy. The nine patients will receive an injection of Indocyanine green (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus. Immediately following endarterectomy, the resected specimen will be immersed in normal saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be performed. The investigators hypothesize that compared to controls, ICG-injected patients will demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of plaque.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

May 23, 2013

Last Update Submit

January 31, 2017

Conditions

AtherosclerosisAtherosclerotic PlaqueCarotid Stenosis

Keywords

AtherosclerosisMolecular ImagingVascular BiologyInflammationFluorescence

Outcome Measures

Primary Outcomes (1)

  • Tissue uptake of indocyanine green in carotid plaque

    Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy

    within 3 months after carotid endarterectomy

Secondary Outcomes (1)

  • Relationship of indocyanine green uptake to carotid plaque histology

    within 3 months after carotid endarterectomy

Study Arms (2)

Injection of Indocyanine Green

EXPERIMENTAL

Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.

Drug: Indocyanine green

No injection

NO INTERVENTION

No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.

Interventions

Indocyanine greenDRUG

Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy

Also known as: FDA Application No. (ANDA) 040811
Injection of Indocyanine Green

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital
  • Age \> 18 years of age.
  • Signed informed consent.

You may not qualify if:

  • Hemodynamic instability
  • Any history of iodide allergy
  • Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) \<50 ml/min/1.73 m2)
  • Any history of liver failure
  • Any history of bleeding diathesis
  • Any history of cerebral vascular accident in the preceding 3 months
  • Pregnant or lactating females.
  • Hx of seafood allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Vinegoni C, Botnaru I, Aikawa E, Calfon MA, Iwamoto Y, Folco EJ, Ntziachristos V, Weissleder R, Libby P, Jaffer FA. Indocyanine green enables near-infrared fluorescence imaging of lipid-rich, inflamed atherosclerotic plaques. Sci Transl Med. 2011 May 25;3(84):84ra45. doi: 10.1126/scitranslmed.3001577.

    PMID: 21613624BACKGROUND

  • Verjans JW, Osborn EA, Ughi GJ, Calfon Press MA, Hamidi E, Antoniadis AP, Papafaklis MI, Conrad MF, Libby P, Stone PH, Cambria RP, Tearney GJ, Jaffer FA. Targeted Near-Infrared Fluorescence Imaging of Atherosclerosis: Clinical and Intracoronary Evaluation of Indocyanine Green. JACC Cardiovasc Imaging. 2016 Sep;9(9):1087-1095. doi: 10.1016/j.jcmg.2016.01.034. Epub 2016 Aug 17.

    PMID: 27544892DERIVED

MeSH Terms

Conditions

AtherosclerosisPlaque, AtheroscleroticCarotid StenosisInflammation

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Farouc A Jaffer, MD PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 10, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-01

Locations

US(1)